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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 3-52
Standard
ANSI AAMI EC12:2000/(R)2015
Disposable ECG electrodes
Scope/Abstract
This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 5.3.2 Pre-attached Leadwire Safety
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Section 5.3.2 conflicts with an existing regulation, see Section 898.12 Performance standard listed below.

Section 5.3.2 conflicts with existing final published guidance, see Section 5 Performance Characteristics listed below.

Section 5.3.2 conflicts with another recognized standard, see ANSI/AAMI EC53 listed below.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§882.1320 Electrode, Cutaneous Class 2 GXY
§870.2360 Electrode, Electrocardiograph Class 2 DRX
Relevant FDA Guidance and/or Supportive Publications
21 CFR 898 Performance Standard for Electrode Lead Wires and Patient Cables.

Class II Special Controls Guidance Document: Electrocardiograph Electrodes - Guidance for Industry and Food and Drug Administration Staff, Issued October 2007.

ANSI/AAMI EC53:2013 ECG trunk cables and patient leadwires.
FDA Technical Contact
 Shawn Forrest
  FDA/OMPT/CDRH/ODE/DCD/CDDB/
  301-796-5554
  shawn.forrest@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Cardiovascular
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